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IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry (IVTCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04520347
Recruitment Status : Enrolling by invitation
First Posted : August 20, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Jason Bradfield, MD, University of California, Los Angeles

Study Description
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Brief Summary:
This is a prospective multi-center international registry. The objective of this registry is to collect prospective data on patients undergoing catheter ablation for Ventricular Tachycardia (VT) and Premature Ventricular Contractions (PVC). The registry will be used for clinical monitoring, research, and quality improvement purposes.

Condition or disease
Ventricular Arrhythmia Ventricular Tachycardia Premature Ventricular Contraction (PVC) Cardiomyopathy

Detailed Description:

Sudden cardiac death (SCD), predominantly due to ventricular tachyarrhythmias, is a leading cause of mortality in the United States and around the world. Catheter ablation of ventricular arrhythmias has proven efficacious in reducing the burden of arrhythmias and reducing implantable cardiac defibrillator (ICD) shocks.

The aim of this study is to create a prospective international database registry that will allow for better assessment of the outcomes of catheter ablation of ventricular arrhythmias. The registry, with approximately 30 participating centers, will help to identify the overall success rates and associated benefits of the procedure and provide more comprehensive data on understudied populations and treatment.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: An International VT Ablation Center Collaborative Group (IVTCC): A Multicenter Ventricular Tachycardia Catheter Ablation Registry
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Ventricular tachycardia (VT) recurrence [ Time Frame: From date of procedure assessed by shock, Anti-Tachycardia Pacing, or repeat procedure, up to 10 years. ]
    Freedom from ventricular tachycardia episodes requiring ICD Intervention (shock or Anti-Tachycardia Pacing) or repeat procedure.


Secondary Outcome Measures :
  1. Rate of complications [ Time Frame: From date of procedure assessed up to 12 months. ]
    Cardiovascular-related and procedure-related major complications and/or adverse events.

  2. Time to transplant or death [ Time Frame: From date of procedure assessed by date of transplant and/or death, up to 10 years. ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ventricular arrhythmias that undergo catheter ablation for ventricular tachycardia or premature ventricular contractions.
Criteria

Inclusion Criteria:

- All patients undergoing catheter ablation for ventricular tachycardia (VT) or premature ventricular contractions (PVCs).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520347


Locations
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Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Jason Bradfield, MD University of California, Los Angeles
Study Chair: Kalyanam Shivkumar, MD, PhD University of California, Los Angeles
Study Chair: Paolo Della Bella, MD San Raffaele Hospital, Italy
Study Chair: Francis Marchlinski, MD, FACC, FAHA, FHRS University of Pennsylvania Health System
Study Chair: Andrea Natale, MD, FACC, FHRS, FESC Texas Cardiac Arrhythmia Institute at St. David's Medical Center
Study Chair: William G Stevenson, MD Vanderbilt Heart and Vascular Institute
More Information
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Responsible Party: Jason Bradfield, MD, Director, Specialized Program for Ventricular Tachycardia, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04520347    
Other Study ID Numbers: 17-001725
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Bradfield, MD, University of California, Los Angeles:
Arrhythmia
Cardiac Conduction System Disease
Sudden Cardiac Death
Implantable Cardiac Defibrillator (ICD)
Additional relevant MeSH terms:
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Cardiomyopathies
Arrhythmias, Cardiac
Tachycardia
Tachycardia, Ventricular
Ventricular Premature Complexes
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease
Cardiac Complexes, Premature